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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク IEC 62366 ： ウィキペディア英語版 IEC 62366 The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets. == Summary of IEC 62366 == The IEC 62366 standard calls out that user errors caused by inadequate medical device usability have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not apply to clinical decision-making that may be related to the use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. Manufacturers of medical electrical equipment who comply with IEC 60601-1-6 need to also comply by extension to IEC 62366 as part of IEC 60601-1 Edition 3.1 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「IEC 62366」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.